In This Issue
1. IACP Announces Fourth-Annual 2015 "Virtual Hill Day"
2. Not too Late to Register for CCH!
3. IACP Submits Comments to FDA on its Proposed Guidance Documents
4. FDA Announces CPG on Veterinary Compounding - IACP Prepares Summary for Members
5. Tricare Implements Extensive New Restrictions
6. FDA Announces CPG on Veterinary Compounding
7. IACP Foundation Update!
8. IACP Welcomes Corporate Partner Spectrum Pharmacy Products
9. Corporate Partner Spotlight: RxCoop
10. Register Today for The Compound Conference 2015!
|Capitol Connections is a biweekly newsletter for IACP Members Only.
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Just Like Being There in Person Without the Travel! IACP Announces Fourth-Annual 2015 “Virtual Hill Day”
On June 6-9, 2015, more than 400 compounding pharmacists and pharmacy technicians just like you will be gathered together for IACP’s 21st Annual Compounders on Capitol Hill conference in Washington, D.C. On Tuesday, June 9th, your colleagues will be pounding the hallways of Congress, meeting with representatives and Senators to educate and secure their support of our legislative agenda.
But you’ve got a business to run. Patients to take care of. Prescriptions to compound, prepare and dispense. You can’t make it to Washington, D.C. this year.
And that’s okay. Because even if you’re not at Compounders on Capitol Hill in person, you can still add your voice along with those of pharmacists nationwide and make a real impact on legislation that can hurt or harm your business and your profession.
Once again, IACP is using technology to put you right there in those hallways and on the Capitol steps… at least virtually. Our unique Action Alert system lets you send a personalized, IACP prepared request for support directly from your home or pharmacy straight to the offices of both your Representative and your Senator.
Watch your in-box on Monday, June 8, 2015 for information and links on how to send a message to Capitol Hill. It takes just a few minutes and can literally quadruple the number of compounding pharmacist voices ringing through the halls of Congress. IACP will be sending you the official 2015 CCH Ask Documents this week. Stay tuned to your email, IACP's website/Breaking News, and our social networking sites!
It’s Not too Late to Register and Attend IACP’s 21st Annual Compounders on Capitol Hill
IACP’s 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 at the Renaissance Washington in Washington, D.C. With an expected 400 total attendees in 2015, CCH brings together the top-level compounding pharmacists and technicians from across the country with the same goal – to protect pharmacy compounding. Don't miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.'s doorstep.
Click here for more CCH details!
Click here to access an onsite CCH registration form.
IACP's May Town Hall Provides Members with CCH Lobbying Tips - Recording Now Available
During last week's Town Hall, IACP Leadership discussed IACP’s 2015 Compounders on Capitol Hill Asks, the new Senate bill to “Fix DQSA,” and how you can participate in this year’s Virtual Hill Day!
No worries if you missed it! Click here for the Town Hall Recording.
IACP Submits Comments to FDA on its Proposed Guidance Documents
Last week, IACP filed comments on the FDA Guidance Documents with the Agency. Please click the below links to view IACP's comments.
FDA's "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities"
"Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act"
"Repackaging of Biologics"
The U.S. Food & Drug Administration (FDA) established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
IACP Summary on FDA Four Draft Guidance Documents and MOU
Please click here to view.
FDA Announces CPG on Veterinary Compounding - IACP Prepares Summary for Members
On Tuesday, May 19, 2015, the Food and Drug Administration released a new proposed guidance document that explains its enforcement policies related to the compounding of veterinary preparations using bulk ingredients. This guidance document, published in The Federal Register as CVM GFI #230 is a draft document. It does not become enforceable or “official” until a comment period is completed and a final version is issued.
The pharmacy profession as well as other stakeholders have 90 days to review and submit comments and questions.
The International Academy of Compounding Pharmacists (IACP) has prepared a summary for you that contains key information on the veterinary compounding with bulk ingredients draft guidance document.
IACP Summary on FDA's Veterinary Compounding Draft Guidance
Please click here to review IACP's summary.
On May 19th, the FDA announced its intent to published a draft guidance document for veterinary compounding. This draft, a copy of which is linked here, will replace the previous 2003 compliance policy guidance. The previous guidance has now been formally rescinded.
•All compounds must be for an individually identified animal. No provisions for office-use.
•Anticipatory compounding is limited to 14 days
•FDA is permitting 503B outsourcing facilities to produce veterinary products
•Mandatory adverse event reporting
•Additional, specific labeling requirements (non-food species)
•Mandatory language on prescription requiring that no FDA alternative exists.
•There will be a limited number of bulk ingredients that may be used to compound by 503B outsourcing facilities.
As written, this draft would significantly and negatively impact veterinary compounders. IACP is carefully reviewing these documents, and will be making formal comments to the FDA. We will share those with our membership as soon as they are available.
Louisiana Senate Committee Passes IACP Supported Legislation
This afternoon, June 2, 2015, the Louisiana Senate Health and Welfare Committee unanimously passed House Bill 568 with amendments, legislation that has been identified by the IACP Board of Directors as a priority state initiative for the Academy. The bill was introduced in early May by state Representative Ledricka Thierry who personally experienced questionable marketing of compounded preparations to herself and her constituents and was passed unanimously by the House Health and Welfare Committee on May 6, followed by full House approval a week later.
As introduced, HB 568 provides the state Board of Pharmacy with statutory authority to investigate complaints about marketing of prescriptions drugs by individuals affiliated with or employed by a pharmacy. Unlike pharmaceutical manufacturers' sales representatives and marketers, which are heavily regulated by the Food and Drug Administration, little or no oversight is provided for at the state level for the promotion and sales of prescription drugs, including compounds. As many IACP members have seen and shared with the Academy leadership, marketers are engaging in all sorts of "schemes" to induce the writing of prescriptions by doctors, including direct payment or other types of remuneration, establishing "studies" which pay doctors for the number of prescriptions they generate for a particular pharmacy, and even instances of cold-call telemarketing to patients' homes to obtain personal health and insurance information.
Please click here to read the entire article.
IACP Foundation Update!
Announcing the 2015 Spring Student Writing Competition Winners
Essay Theme: "Should States Institute a 'Wet Lab' Examination as Part of the Pharmacist Licensing Process?"
The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers on a particular topic affecting pharmacy compounding. THREE winners are selected by a review committee from the papers submitted. The winners of this writing competition each receive a $500 cash prize.
And the Winners Are...
Due to the fantastic response this year, the IACP Foundation is pleased to announce four winners rather than three. This year, we also had a tie, and wanted to acknowledge the excellent work of our applicants. Congratulations to all!
Please click here to view the winners and their respective essays.
Student Pharmacist Travel Stipend Grants: Compounders on Capitol Hill - 2015
Through the generosity of donors to our Fund-the-Future campaign, the IACP Foundation is providing pharmacy students a travel stipend to attend the International Academy of Compounding Pharmacists’ annual meeting -- Compounders on Capitol Hill -- June 6 - 9, 2015, in Washington, DC.
Congratulations to our 2015 Fund-the-Future Student Travel Stipend Winners!
Please click here to view.
IACPublications are Available!
The Spring issues of Compounding Matters Quarterly & Pharmacy Marketing Quarterly are now available online for viewing on your computer or smart device. Printed copies are arriving soon! And if you’re attending Compounders on Capitol Hill, you can pick up a copy there as well.
A few highlights from this issue:
- A Note From The President
- Six Things I Have Learned From Compounding Pharmacy Crises
- The Memorandum Of Understanding What It Is, What It Says, And What Happens Next
- IACP Foundation History Part 1 - Google Launches Small-Business Initiative
- Making The Most Of Exhibiting At Trade Shows
- Meet Me In Denver
- Hill Day: The What Not To Wear Edition
- Top Travel Tips From A Road Warrior
And speaking of Compounders on Capitol Hill, be sure to check out Episode 6 of the IACPodcast generously sponsored by The Compounders Group.
Have an idea for a topic? Want to give us a suggestion? Maybe you have a question? Give us a call at the IACPublication line: 713-730-9043.
IACP Welcomes Corporate Partner: Spectrum Pharmacy Products
The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 members who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support IACP's 73 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.
To learn more about Spectrum Pharmacy Products, please visit www.spectrumpharmacy.com.
FDA Drug Shortage App
FDA Launches Drug Shortage App
What's New on the FDA Drugs Site
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
The FDA Drug Shortage Report
Please click here for the most recent Drug Shortage information.
IACP Member Q&A
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. In every issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members. If you have a question you'd like answered, please send to email@example.com.
What is the current Do Not Compound list from FDA? What is the status?
• A link to the current "do not compound" list from the FDA:
•The slides from a recent IACP webinar -- in particular, see slides 25-34. These include the list of drugs that were published in the Federal Register and approved by the Pharmacy Compounding Advisory Committee for inclusion on the revised list.
Remember, the revised list has not yet been formally promulgated and published. We're in a waiting period at this point.
Corporate Partner Spotlight: RxCoop
RxCoop is a buying group (GPO) and supplier for compounding pharmacies. On behalf of our Member pharmacies, we provide a catalog of discounted pricing on chemicals, supplies, and equipment from various wholesalers, chemical sourcing of hard to find products, group buying of chemicals, and innovative pharmacy programs. Working with major compounding wholesalers, our mission is to represent our Members as a Group and obtain price saving based on our Member’s total purchasing power in order to lower overall cost of goods.
Please click here to learn more about RxCoop.
21st Annual Compounders on Capitol Hill Kicks off this Saturday, June 6, 2015.
See You in DC!
The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2015, Compounders on Capitol Hill brings together the top-level compounding pharmacists and technicians from across the country with the same goal – to protect pharmacy compounding. Don’t miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.’s doorstep.
CCH returns to Downtown Washington, D.C.! Conveniently situated in the Penn Quarter district, this premier location is surrounded by shops, a variety of dining options, the Spy Museum, Chinatown, the National Portrait Gallery, the Smithsonian American Art Museum, and world-famous National Mall monuments. Click here to read more!
Click here for an onsite CCH registration form.
CCH e-Brochure Available! Click here to view.
Thanks to IACP Corporate Partner Freedom Pharmaceuticals for generously sponsoring the CCH e-Brochure.
Save the Date for Rx Mixer!
Lots of blue eye shadow, acid washed jeans with popped-up shirt collars, fingerless lace gloves, giant hair bows, and layers of beaded necklaces are totally tubular once again for Rewind: Back to the 80s— the theme for IACP Foundation’s 11th Annual Rx Mixer, a fundraising event to be held in conjunction with IACP’s 21st Annual Compounders on Capitol Hill (CCH), Sunday, June 7, 2015!
Travel back to the place where you uttered slang phrases like “gag me with a spoon,” “like, totally,” “gnarly,” “grody,” “grody to the max,” “rad,” “awesome,” or any combination of these words excessively. If your hairdresser couldn’t stop laughing long enough to actually give you the Flock of Seagulls haircut you wanted. And, if you still know all the dance moves to “Thriller.” You know you belong to the 80s.
It's not too late to score those Rx Mixer tickets. Click here, or you can buy them onsite at the event.
Click here or the graphic above to view the Rx Mixer 2015 Auction Program with amazing items on which to bid! Thanks to IACP Corproate Partner Letco Medical for generously sponsoring the auction program.
IACP Regional Education Meeting Heading to Chicago, IL - July 23rd!
The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States. Listen to David G. Miller, RPh, IACP’s Executive Vice President & CEO as he presents Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today.
Click here for more information!
Register Today for the Compound Conference 2015!
The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession. At the Compound Conference, attendees have an unprecedented opportunity to meet face-to-face with compounding pharmacists, technicians, and marketing representatives in their home state.
Offering a variety of Continuing Education sessions focused on understanding the essentials in building a compounding practice, the 2015 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA) and the International Academy of Compounding Pharmacists (IACP). Don’t miss this unique conference bringing together two leading pharmacy associations, August 15, 2015 at the Hilton Columbus at Easton in Columbus, Ohio.
We would like to thank the following exhibitors for their commitment to the Compound Conference: Analytical Research Laboratories (ARL); ASI; Associate of Cape Cod, Inc.; Biomerieux; Cleanroom Design LLC; Letco Medical; MEDISCA; PCCA; Pharmacists Mutual Companies; Rx30 Pharmacy System; Storey Marketing; Topi-CLICK; Topi-Pump
Please click here to view The Compound Conference eBrochure.
Need CE ASAP? Check out the IACP AdvanCE On-Demand Library!
If you need CE credit, check out IACP's AdvanCE's on-demand library, which houses more than 100 programs on various pharmacy topics. Please click here to access the self-paced programs.
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